Early Syphilis, Symptomatic, Syphilis, Syphilis Infection
Conditions
Keywords
Rapid Vertical Flow (RVF), Reveal TP, Syphilis, POCT, MedMira
Brief summary
This study is to test the Reveal® TP (Syphilis) antibody POCT (MedMira, Inc., Halifax, Nova Scotia) for its performance in an urban STI clinic in Vancouver, British Columbia and compare its performance in parallel with the usual testing method (the gold standard).
Detailed description
This study is to test the Reveal® TP (Syphilis) antibody POCT (MedMira, Inc., Halifax, Nova Scotia) for its performance in an urban STI clinic in Vancouver, British Columbia and compare its performance in parallel with the usual testing method (the gold standard). The healthcare professional will advise patients about the study, and with their permission refer them to research staff for recruitment. Should patients choose to participate in the study they will be asked to provide consent to have a few drops of blood sample obtained through a finger prick to be used in the POCT. POCT results will not be provided to participants and this will be explained in both the recruitment script and informed consent form. A sample of 5 to 10 ml venous whole blood will also be obtained for the conventional syphilis serology testing which is part of the routine for care of the four categories of patients (regardless of this research). This research will take approximately 15 to 30 minutes and will be on top of the regular care that patients will receive in the clinic. Upon completing the tests, participants will be asked to complete a brief feedback survey to assess patients' acceptability of syphilis POCT.
Interventions
DEVICEReveal TP (Syphilis) Antibody Test
All subjects tested with both investigational devices and conventional syphilis serology tests.
Sponsors
MedMira Laboratories Inc.
Public Health Agency of Canada (PHAC)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
The result of the Reveal TP (Syphilis) Antibody Test will not be revealed to the participant.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult patients 19 years of age and above attending the BCCDC STI Clinic in Vancouver, British Columbia for routine sexual health care and requiring syphilis testing as part of this care are eligible for this study. * Additionally, for each participant category: * Group 1: No known (i.e. self-reported or laboratory documented history of syphilis) prior history of syphilis. * Group 2: No additional inclusion criteria * Group 3: Participants were named as a contact by a confirmed syphilis case within the last year, and have not yet received treatment * Group 4: No additional inclusion criteria * Those who had other STIs in the past or being suspected of having other STIs are not excluded as long as testing for syphilis is part of the care provided to them. Once it has been determined that the
Exclusion criteria
does not apply to a patient, the recruitment of the four categories of participants will be offered without other pre-selection criteria unless there may be other unforeseeable circumstances arising, such as shortage of clinic staff or large number of patients showing up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the accuracy of Reveal TP (Syphilis) Antibody Test | 1 patient visit of approximately 30 minutes | For each enrolled subject, Reveal TP (Syphilis) Antibody Test will be used to test fingerstick whole blood from the patient. A venipuncture whole blood sample will also be drawn from the patient and will be tested using conventional serological testing methods to determine patient status. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORTroy Grennan, Dr
British Columbia Center for Disease Control (BCCDC)
PRINCIPAL_INVESTIGATORRaymond Tsang, Dr
National Microbiology Laboratory Branch, Public Health Agency of Canada
Outcome results
None listed